ROCKVILLE, Md. - Theriva Biologics (NYSE American: TOVX), a clinical-stage biopharmaceutical company with a market capitalization of $3.7 million, has announced the outcomes of its recent Type D meeting with the U.S. Food and Drug Administration (FDA) regarding the Phase 3 clinical study design for its leading candidate VCN-01. According to InvestingPro data, the company's stock has seen significant volatility, declining over 90% in the past year, though current analysis suggests the stock may be undervalued. The drug, in combination with standard-of-care chemotherapy, is being developed for the treatment of metastatic pancreatic adenocarcinoma (PDAC).
The FDA advised against expanding the ongoing VIRAGE Phase 2b study into a Phase 3 study. Instead, the agency recommended a separate Phase 3 study for VCN-01 with gemcitabine/nab-paclitaxel, affirming the proposed design without additional standard-of-care chemotherapy. This approach aims to avoid complications in study design and analysis. InvestingPro analysis reveals the company maintains a healthy current ratio of 2.67, indicating sufficient liquidity to fund its clinical programs, though it's worth noting the company is quickly burning through its cash reserves.
The VIRAGE study, which has reached its target enrollment, is evaluating VCN-01 as a first-line therapy for PDAC patients. As the study enters its final patient follow-up phase, the FDA's guidance is crucial for the next development steps of VCN-01.
Steven A. Shallcross, CEO of Theriva Biologics, emphasized the importance of the FDA's feedback in designing a Phase 3 protocol to provide a new therapeutic option for patients with this challenging disease. Following the completion of the VIRAGE study, an additional meeting with the FDA will be sought to discuss the details of the Phase 3 protocol.
VCN-01 is an oncolytic adenovirus that selectively replicates within tumor cells, degrades tumor stroma, and enhances the efficacy of co-administered chemotherapy. It also increases tumor immunogenicity, potentially leading to a stronger immune response. The drug has been administered to 142 patients across various cancers in clinical trials.
Theriva Biologics, with its focus on developing treatments for high unmet needs in cancer and related diseases, is advancing a portfolio of therapeutic candidates designed to trigger tumor cell death and promote an anti-tumor response.
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In other recent news, Theriva Biologics has gained EU orphan drug status for its clinical candidate VCN-01, a treatment for retinoblastoma, a rare form of eye cancer. This development follows the United States Food and Drug Administration's similar designation for VCN-01. The company has reported positive outcomes from a Phase 1 trial assessing VCN-01's safety and activity, and is refining its clinical approach in collaboration with medical experts and regulatory bodies.
Additionally, Theriva Biologics has seen progress in the clinical trial of its drug SYN-004, designed to prevent acute graft-versus-host-disease in recipients of allogeneic hematopoietic cell transplants. Initial findings suggest that adverse events were typical for allo-HCT patients and not related to the study drug.
In a strategic move, Theriva Biologics has also announced a reverse stock split of its common stock at a 1-for-25 ratio. Furthermore, the U.S. Food and Drug Administration has granted Theriva's VCN-01 both Rare Pediatric Drug Designation and Fast Track Designation for treating metastatic pancreatic adenocarcinoma in combination with chemotherapy drugs. The VIRAGE Phase 2b trial, investigating the efficacy of VCN-01, is expected to complete patient enrollment by the third quarter of 2024. These are all recent developments in Theriva Biologics' ongoing commitment to address unmet medical needs in oncology.
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